Pharmaceuticals Solutions

Our services to the pharmaceuticals industry are based on practical experience of successfully managing projects to establish an electronic data archive in one of the world’s largest pharmaceutical companies.

The FDA’s regulation 21 CFR Part 11 introduces a legal imperative to archive electronic data. Being compliant, solving the problems of longevity and to do it in a way which is cost effective, technically sound and long lasting is a significant challenge.

Our services are designed to assist companies formulate strategies and take practical steps to address these challenges.

We provide consultancy services to:

Interpret the FDA’s 21 CFR Part 11 ruling and guidelines on data archiving in the context of our clients’ own organisations, developing road-maps to enable solutions tailored to their specific circumstances.

Provide management briefings, training seminars and courses on how to move towards full compliance.

Assess needs and their impact on the organisation.

Analyse the options available, assessing costs, benefits and risks.

Build and successfully promote the business case to establish cost-effective electronic archives.

Quantifying the problem – how much information, what information to archive, characterising it from both business and technical perspectives.

Archiving electronic information is an activity that has an impact on many areas of a company’s activities. Although it can be seen as presenting significant organisational and cost issues, it can reduce risks and open opportunities for maximising information value.